Novo Nordisk Secures Landmark FDA Approval for Weight-Loss Pill

Investors in the Danish pharmaceutical giant have reason for optimism following a prolonged downturn. The U.S. Food and Drug Administration (FDA) has granted approval for the first oral GLP-1 tablet, providing Novo Nordisk with a crucial strategic edge over its main competitor, Eli Lilly. This regulatory milestone arrives as the company's shares, which have undergone a significant correction, search for a sustainable floor.

• Regulatory Milestone: First oral GLP-1 drug for weight management receives FDA clearance.
• Competitive Lead: U.S. market launch is scheduled for early January 2026.
• Market Response: The stock advanced by as much as 8% in the days following the announcement.

The FDA's decision on December 22nd represents a paradigm shift in obesity treatment. Novo Nordisk's Wegovy tablet introduces the first therapy that delivers the active ingredient semaglutid without requiring an injection. Clinical data from the OASIS-4 study are compelling, showing participants achieved an average weight reduction of 16.6%. This efficacy is comparable to the injectable version, which demonstrated approximately 15% weight loss in trials. The monthly list price for self-pay patients has been set at $149.

This achievement grants Novo a vital head start in a fiercely competitive market. Eli Lilly's competing oral drug, Orforglipron, is not expected to receive an FDA decision until spring 2026. Consequently, Novo Nordisk can begin its distribution campaign in January, securing a potential 90-day lead. In the rapidly expanding market for weight-loss medications, this window could be decisive for capturing early market share.

The news comes at a pivotal moment for Novo Nordisk's equity. The share price currently trades approximately 63% below its 52-week high of $142.44. This recent decline has pushed the price-to-earnings (P/E) ratio down to around 14, a figure notably lower than its ten-year average of 27.

Should investors sell immediately? Or is it worth buying Novo Nordisk?

Navigating a Complex Landscape

Despite this regulatory breakthrough, the company continues to face a multifaceted set of challenges. The latter part of 2025 was marked by disappointing Alzheimer's trial data in November, which triggered substantial selling pressure. Concurrently, a global restructuring initiative is underway, involving the reduction of roughly 9,000 positions worldwide.

Simultaneously, Novo is investing approximately 65 billion Danish kroner to expand its production capacity, aiming to meet the soaring demand for GLP-1 therapies. This product category is responsible for about two-thirds of the company's total revenue.

With the tablet's launch in January 2026, Novo Nordisk is strategically targeting patient groups who are averse to injections. Market analysts see significant potential here, as estimates suggest only one in eight eligible U.S. adults currently uses GLP-1 medications. Looking ahead, investors must monitor upcoming price negotiations with Medicare, set to begin in 2027, which could pressure the profit margins of top-selling drugs in the United States.